Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application to the FDA for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. Sodium oxybate is currently marketed as Xyrem and is thus far only approved for the treatment of excessive daytime sleepiness and cataplexy associated with narcolepsy.
The submission requesting approval for the treatment of FM was based on a comprehensive clinical development program for JZP-6, including results from two Phase...
